San Clemente, CA, United States
ICU Medical, Inc. recalls
56 recalls recorded since 2018, most recently on 20 August 2026. 30 are listed as ongoing. Status and classification are as published by the FDA.
Recalls56
Ongoing (FDA)30
Terminated or completed26
Class I (FDA)11
Ongoing Class II Medical devices
- Recall started
- 20 August 2026
- Reason
- Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3212-2026
- CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-760
Ongoing Class II Medical devices
- Recall started
- 24 June 2026
- Reason
- ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2759-2026
- Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Nu
Ongoing Class II Medical devices
- Recall started
- 10 June 2026
- Reason
- In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2723-2026, Z-2724-2026
- ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Ongoing Class II Medical devices
- Recall started
- 12 May 2026
- Reason
- Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
- Distribution
- Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3159-2026, Z-3158-2026, Z-3160-2026, Z-3156-2026, Z-3161-2026, Z-3157-2026, Z-3162-2026, Z-3163-2026
- Oncology sets with drip chambers
- Oncology sets with drip chambers
- IV Sets with drip chambers
- Plum administration sets
- IV Sets with drip chambers
- IV Non-Dedicated Gravity Administration Sets with drip chambers
- IV Sets with drip chambers
- IV Sets with drip chambers
Ongoing Class II Medical devices
- Recall started
- 29 April 2026
- Reason
- Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- Distribution
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2313-2026, Z-2312-2026, Z-2311-2026
- Plum Duo Precision IV Pump, 40002-0403
- Plum Duo Infusion Pump, 40002-0401
- Plum Solo Precision IV Pump, 40001-0401
Ongoing Class II Medical devices
- Recall started
- 24 March 2026
- Reason
- Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- Distribution
- US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2210-2026
- Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- Reason
- Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
- Distribution
- Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1111-2026
- Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- Reason
- Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1100-2026, Z-1101-2026
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Portex Spinal Tray, Item No. A3729-24 A3595
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Distribution
- Worldwide distribution - US Nationwide and the country of Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1118-2026, Z-1120-2026, Z-1119-2026
- ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
- ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1094-2026
- Plum Duo Infusion System, List Number 40002-04-01
Ongoing Class II Medical devices
- Recall started
- 24 November 2025
- Reason
- For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0965-2026
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Ongoing Class II Medical devices
- Recall started
- 24 November 2025
- Reason
- Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
- Distribution
- US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0966-2026
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Ongoing Class I Medical devices
- Recall started
- 2 October 2025
- Reason
- IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
- Distribution
- Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0154-2026
- IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (
Ongoing Class II Medical devices
- Recall started
- 8 September 2025
- Reason
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Distribution
- Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0348-2026, Z-0357-2026, Z-0330-2026, Z-0364-2026, Z-0356-2026, Z-0354-2026, Z-0329-2026, Z-0351-2026, Z-0353-2026, Z-0332-2026, Z-0365-2026, Z-0337-2026 and 26 more
- ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
- ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
- ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
- ICU Medical ChemosafeLock Connecter REF: KL-FNU3
- ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
- ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
- ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
- ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
- and 30 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 August 2025
- Reason
- Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2522-2025, Z-2526-2025, Z-2527-2025, Z-2523-2025, Z-2525-2025, Z-2524-2025
- Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
- Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
- Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
- Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
- Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
- Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Ongoing Class I Medical devices
- Recall started
- 11 July 2025
- Reason
- ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2129-2025
- Plum Duo Infusion System, List Number: 400020401
Ongoing Class II Medical devices
- Recall started
- 3 June 2025
- Reason
- Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
- Distribution
- Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2116-2025
- SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Ongoing Class II Medical devices
- Recall started
- 2 May 2025
- Reason
- Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1763-2025
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Ongoing Class II Medical devices
- Recall started
- 22 April 2025
- Reason
- Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1991-2025, Z-1990-2025
- ICU Medical Plum Solos, Item number 400011001; infusion pump
- ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Ongoing Class I Drugs
- Recall started
- 13 February 2025
- Reason
- Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0268-2025, D-0267-2025
- POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
- POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266;
Ongoing Class II Medical devices
- Recall started
- 6 November 2024
- Reason
- Due to finished goods incorrectly packaged and labeled.
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0652-2025
- ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid i
Ongoing Class I Medical devices
- Recall started
- 22 October 2024
- Reason
- ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
- Distribution
- Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingd
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0482-2025
- Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11
Ongoing Class I Medical devices
- Recall started
- 7 May 2024
- Reason
- Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2448-2024, Z-2449-2024, Z-2447-2024
- Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with
- Plum 360/A+ spare batteries. Item Number: SUB0000864.
- Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360
Ongoing Class II Medical devices
- Recall started
- 13 July 2023
- Reason
- Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2430-2023
- Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300
Ongoing Class I Medical devices
- Recall started
- 22 March 2023
- Reason
- Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1565-2023, Z-1567-2023, Z-1568-2023, Z-1566-2023
- Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
- ASM Replacement Battery, Component Number SUB0000864
- ASM Replacement Battery, Component Number SUB0000594
- Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Ongoing Class II Drugs
- Recall started
- 9 November 2022
- Reason
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0062-2023
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Ongoing Class II Medical devices
- Recall started
- 1 August 2022
- Reason
- Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, Fran
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1723-2022, Z-1722-2022, Z-1724-2022, Z-1719-2022, Z-1720-2022, Z-1721-2022
- 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
- MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
- 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
- MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
- 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
- 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Ongoing Class II Medical devices
- Recall started
- 27 June 2022
- Reason
- Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1681-2022, Z-1682-2022
- Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port,
- Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 c
Terminated Class I Drugs
- Recall started
- 3 September 2021
- Terminated
- 12 July 2023
- Reason
- Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0805-2021
- AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Ongoing Class II Medical devices
- Recall started
- 16 March 2021
- Reason
- Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1573-2021, Z-1577-2021, Z-1578-2021, Z-1574-2021, Z-1565-2021, Z-1566-2021, Z-1567-2021, Z-1571-2021, Z-1585-2021, Z-1582-2021, Z-1579-2021, Z-1583-2021 and 14 more
- REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patien
- REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (wh
- REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s
- REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides acce
- REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
- REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
- REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients
- REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from
- and 18 more product lines
Terminated Class II Drugs
- Recall started
- 9 March 2021
- Terminated
- 28 September 2022
- Reason
- Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
- Distribution
- Distributed Nationwide in the USA to include Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0313-2021
- 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
Terminated Class II Medical devices
- Recall started
- 2 December 2020
- Terminated
- 30 June 2023
- Reason
- Due to the incorrect filter assembly.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0956-2021, Z-0958-2021, Z-0957-2021, Z-0955-2021
- 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, w
- 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids fr
- 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of f
- 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of
Terminated Class II Medical devices
- Recall started
- 9 November 2020
- Terminated
- 19 April 2023
- Reason
- Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
- Distribution
- U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0859-2021
- icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognosti
Ongoing Class II Medical devices
- Recall started
- 31 August 2020
- Reason
- Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countrie
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0703-2021, Z-0711-2021, Z-0699-2021, Z-0706-2021, Z-0705-2021, Z-0701-2021, Z-0710-2021, Z-0708-2021, Z-0702-2021, Z-0709-2021, Z-0707-2021, Z-0704-2021 and 1 more
- 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag
- 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
- 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml,
- Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 m
- 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
- 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/
- Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
- 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 6 July 2020
- Terminated
- 11 May 2023
- Reason
- Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Distribution
- Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Sa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0272-2021, Z-0218-2021, Z-0186-2021, Z-0258-2021, Z-0247-2021, Z-0220-2021, Z-0221-2021, Z-0210-2021, Z-0207-2021, Z-0187-2021, Z-0204-2021, Z-0230-2021 and 87 more
- APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets and their accessories
- 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)250201(30)50(10)47248
- 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718; (01)10887709051048(17)25
- 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709079127(17)250201(30)2
- 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravascular Administration Set is a single us
- Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545.
- 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)4548244. The Intravascular Administr
- 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968.
- and 91 more product lines
Terminated Class II Medical devices
- Recall started
- 1 July 2020
- Terminated
- 1 December 2022
- Reason
- Incorrect filter assemblies in IV administration set.
- Distribution
- U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0511-2021
- REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration
Terminated Class I Drugs
- Recall started
- 8 May 2020
- Terminated
- 10 November 2021
- Reason
- Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1270-2020
- LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Terminated Class II Medical devices
- Recall started
- 14 February 2020
- Terminated
- 3 May 2023
- Reason
- Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
- Distribution
- US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1927-2020
- The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for w
Terminated Class II Medical devices
- Recall started
- 2 January 2020
- Terminated
- 14 September 2022
- Reason
- Inability for the guidewire to pass through the needles included with the catheter kits.
- Distribution
- US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2001-2020, Z-1996-2020, Z-2002-2020, Z-1998-2020, Z-1997-2020, Z-1999-2020, Z-2000-2020
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
- Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
Terminated Class I Drugs
- Recall started
- 25 October 2019
- Terminated
- 20 January 2022
- Reason
- Presence of Particulate Matter.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0350-2020, D-0349-2020
- 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
- LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Terminated Class II Medical devices
- Recall started
- 4 October 2019
- Terminated
- 28 December 2021
- Reason
- There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
- Distribution
- US:AK,AL,AR,AZ,CA,CO,CT,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,SD,TN,TX,UT,VA,WA,WI,WY OUS: Canada *** "REF" numbers AH7117 and B30211 were not marketed or distributed within the US***
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1917-2020, Z-1916-2020, Z-1913-2020, Z-1918-2020, Z-1911-2020, Z-1912-2020, Z-1915-2020, Z-1919-2020, Z-1920-2020, Z-1914-2020
- REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
- REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
- REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
- REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
- REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
- REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
- REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
- REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 29 July 2019
- Terminated
- 12 January 2024
- Reason
- Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Ger
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0127-2020, Z-0134-2020, Z-0130-2020, Z-0143-2020, Z-0131-2020, Z-0145-2020, Z-0146-2020, Z-0144-2020, Z-0141-2020, Z-0139-2020, Z-0126-2020, Z-0138-2020 and 10 more
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbo
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches pe
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 b
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches p
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 In
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 u
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 b
- and 14 more product lines
Terminated Class II Medical devices
- Recall started
- 12 July 2019
- Terminated
- 10 May 2023
- Reason
- Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
- Distribution
- US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1835-2020
- ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Terminated Class I Medical devices
- Recall started
- 21 February 2019
- Terminated
- 4 June 2024
- Reason
- There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
- Distribution
- Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1097-2019, Z-1098-2019, Z-1093-2019, Z-1092-2019, Z-1095-2019, Z-1096-2019, Z-1094-2019
- icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of
- SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental
- icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environment
- icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmen
- icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets
- icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, incl
- icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. T
Terminated Class II Drugs
- Recall started
- 4 February 2019
- Terminated
- 4 June 2020
- Reason
- CGMP Deviations
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0509-2019
- 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Terminated Class I Medical devices
- Recall started
- 3 January 2019
- Terminated
- 29 May 2024
- Reason
- There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
- Distribution
- US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0805-2019
- icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, a
Terminated Class II Medical devices
- Recall started
- 27 November 2018
- Terminated
- 1 February 2022
- Reason
- Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
- Distribution
- U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1070-2019, Z-1072-2019, Z-1071-2019
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
Terminated Class II Medical devices
- Recall started
- 8 November 2018
- Terminated
- 13 October 2020
- Reason
- There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
- Distribution
- US distribution and Internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0619-2019
- SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Se
Terminated Class II Drugs
- Recall started
- 8 October 2018
- Terminated
- 8 March 2021
- Reason
- Lack of Assurance of Sterility; bags have the potential to leak
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0216-2019, D-0215-2019
- 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
- 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Terminated Class II Medical devices
- Recall started
- 5 October 2018
- Terminated
- 25 March 2021
- Reason
- Potential for leakage due to defect in the thermoset check valve component.
- Distribution
- United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0663-2019, Z-0661-2019, Z-0662-2019
- Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
- Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
- Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Completed Class II Medical devices
- Recall started
- 20 August 2018
- Reason
- Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
- Distribution
- U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0069-2019
- ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration
Terminated Class II Medical devices
- Recall started
- 1 August 2018
- Terminated
- 27 April 2021
- Reason
- A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
- Distribution
- US nationwide distribution, and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0171-2020
- Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Terminated Class II Drugs
- Recall started
- 31 May 2018
- Terminated
- 4 June 2020
- Reason
- Lack of assurance of sterility: Bags have potential to leak.
- Distribution
- Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0882-2018, D-0885-2018, D-0884-2018, D-0883-2018, D-0881-2018
- 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
- 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
- 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
- 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
- 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Terminated Class II Medical devices
- Recall started
- 5 February 2018
- Terminated
- 17 September 2019
- Reason
- The infusion sets were manufactured with an incorrect spin collar.
- Distribution
- Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1342-2018, Z-1347-2018, Z-1346-2018, Z-1344-2018, Z-1343-2018, Z-1345-2018
- 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA.
- 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Int
- 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Admi
- 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use,
- 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, C
- 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administ
Terminated Class II Medical devices
- Recall started
- 5 January 2018
- Terminated
- 18 March 2019
- Reason
- When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
- Distribution
- Distributed to the states of CA, FL, NC, NE, NY, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1775-2018
- Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous card
Terminated Class II Medical devices
- Recall started
- 31 July 2017
- Terminated
- 12 March 2019
- Reason
- Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
- Distribution
- Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2621-2018, Z-2641-2018, Z-2658-2018, Z-2613-2018, Z-2646-2018, Z-2625-2018, Z-2653-2018, Z-2634-2018, Z-2643-2018, Z-2652-2018, Z-2648-2018, Z-2650-2018 and 41 more
- 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device
- 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended
- 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyroge
- Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fre
- 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic de
- 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as
- 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic devic
- 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector
- and 45 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.